
Industrial GMP Peptide Synthesizer

Industrial GMP Peptide Synthesizer
Mechotech designs and manufactures industrial single-channel solid-phase peptide synthesizers built for GMP peptide manufacturing at production scale. The system centres on a jacketed reaction tank — configurable from 10 L to 5000 L — in which the resin-bound peptide is assembled through precisely controlled, automated coupling, deprotection and wash cycles. Precise liquid dispensing, inert-gas pressure feed of reagents, jacketed temperature control and online flow metering on each solvent line give the repeatable, well-documented process that regulated peptide production demands. Available in EX-proof (EXD IIB T4 / IP65) or standard non-EX construction with local and remote control, the platform scales classical SPPS chemistry from clinical batches through to commercial active-pharmaceutical-ingredient manufacture.
A Mechotech industrial peptide synthesizer is engineered around a jacketed, agitated reaction tank served by metering pumps, inert-gas pressure feed and dedicated flow meters on every solvent and reagent line, so each addition is delivered accurately and recorded. Reagents are transferred under nitrogen pressure to keep the process inert and moisture-free, while the tank jacket holds coupling and deprotection steps at their set temperature for consistent reaction kinetics. Between steps a 360° clean-in-place (CIP) system flushes the vessel and internals to prevent carry-over and support cleaning validation, and both local touchscreen and remote supervisory control give operators full visibility of the batch. The unit is offered with an optional integrated cleavage module to release the peptide from the resin and remove side-chain protecting groups, closing the loop from assembly to crude peptide. Reactor volume, material of construction, hazardous-area rating and automation level are all specified to the customer's product, batch size and facility, and the 21 CFR Part 11 control software provides the audit trails and electronic records required for GMP.
Technical Specifications
| Technology | Industrial single-channel solid-phase peptide synthesis (SPPS) |
|---|---|
| Synthesis Strategy | t-Boc and Fmoc (configurable) |
| Reaction Tank Volume | 10 L to 5000 L (customizable) |
| Vessel Type | Jacketed, agitated reaction tank |
| Reagent Feed | Inert-gas (nitrogen) pressure feed |
| Liquid Dispensing | Precise metered dispensing per line |
| Flow Measurement | Online flow meter on each solvent / reagent line |
| Temperature Control | Jacketed heating / cooling (configurable range) |
| Cleaning | 360° clean-in-place (CIP) |
| Hazardous-Area Rating | EX-proof EXD IIB T4 / IP65, or non-EX (configurable) |
| Control | Local touchscreen and remote supervisory control |
| Software | FDA 21 CFR Part 11 compliant, with audit trail and e-records |
| Cleavage Unit | Optional integrated module |
| Product-contact Material | Stainless steel 316L / chemically resistant lining |
Plant Capacities
| Reactor Volume | Scale / Usage | Construction | Control | Rating |
|---|---|---|---|---|
| 10 L | Clinical / pilot batches | SS 316L jacketed | Local + remote | EX-proof or non-EX |
| 20 L | Clinical / pilot batches | SS 316L jacketed | Local + remote | EX-proof or non-EX |
| 50 L | Small GMP production | SS 316L jacketed | Local + remote | EX-proof or non-EX |
| 100 L | GMP production | SS 316L jacketed | Local + remote | EX-proof or non-EX |
| 300 L | GMP production | SS 316L jacketed | Local + remote | EX-proof or non-EX |
| 500 L | Commercial API | SS 316L jacketed | Local + remote | EX-proof or non-EX |
| 1000 L | Commercial API | SS 316L jacketed | Local + remote | EX-proof or non-EX |
| 3000 L | Large-scale API | SS 316L jacketed | Local + remote | EX-proof or non-EX |
| 5000 L | Large-scale API | SS 316L jacketed | Local + remote | EX-proof or non-EX |
Reaction-tank sizes are fully customizable; the metering pumps, pressure-feed system, flow meters, CIP, temperature control, hazardous-area rating and optional cleavage unit are scaled to each reactor. Volumes shown are typical steps in the ladder — intermediate and larger custom sizes on request.
Manufacturing Process
Resin Charging & Swelling
Resin is loaded into the jacketed reaction tank and swelled in solvent under agitation, forming the support on which the peptide chain will be assembled.
Reagent Pressure Feed
Amino-acid, activator, deprotection and wash solutions are transferred under inert-gas pressure through metered lines, each monitored by an online flow meter.
Coupling
The activated amino acid is dosed into the vessel and mixed under jacketed temperature control, forming the amide bond under repeatable, inert conditions.
Solvent Washing
Programmed solvent washes flush excess reagents and by-products from the resin bed, with drained volumes tracked by the flow-metering system.
Deprotection
The temporary N-terminal protecting group is removed under controlled temperature and time so the amine is ready for the next coupling cycle.
Cycle Repetition
Coupling, washing and deprotection repeat for every residue in the sequence under recipe control, with each step logged for full batch traceability.
360° Clean-in-Place
The integrated CIP system spray-cleans the vessel and internals between batches to prevent cross-contamination and support cleaning validation.
Cleavage (Optional Module)
The optional cleavage unit releases the peptide from the resin and removes side-chain protection, delivering crude peptide ready for downstream purification.
Applications
- GMP manufacture of peptide active pharmaceutical ingredients (APIs)
- Clinical-batch and commercial-scale peptide production
- Peptide therapeutics and hormone analogues
- Peptide-based vaccine antigens at production scale
- Cosmetic and nutraceutical peptide manufacturing
- Contract development and manufacturing (CDMO) peptide services
- Scale-up of validated research sequences to kilo-scale batches
- Diagnostic and reference-standard peptide production
Key Features
Scalable 10 L–5000 L Reactor
A jacketed reaction tank configurable from 10 L to 5000 L takes classical SPPS chemistry from clinical batches to commercial API manufacture.
Inert-Gas Pressure Feed & Flow Metering
Reagents are fed under nitrogen pressure with an online flow meter on each solvent line for accurate, inert, fully documented additions.
Jacketed Temperature Control
The tank jacket holds coupling and deprotection steps at set temperature for consistent reaction kinetics and reproducible batches.
360° Clean-in-Place
An integrated CIP system spray-cleans the vessel and internals between batches to prevent carry-over and support cleaning validation.
EX-Proof or Non-EX Options
Available in hazardous-area EX-proof construction (EXD IIB T4 / IP65) or standard non-EX build, with local touchscreen and remote control.
Optional Integrated Cleavage Unit
An optional cleavage module releases the peptide from the resin and removes side-chain protection, delivering crude peptide in-line.
Frequently Asked Questions
What is an industrial peptide synthesizer?
What reactor sizes are available?
Is the system suitable for GMP manufacturing?
Can it be used in a hazardous area?
Does it include cleavage of the peptide from the resin?
How is the vessel cleaned between batches?
Does Mechotech supply it turnkey?
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